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KemPharm gains FDA approval for prodrug, acetaminophen combination to manage short-term acute pain

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KemPharm Inc. announced the FDA has approved its new drug application for Apadaz, which is an immediate release combination of the KemPharm’s prodrug benzhydrocodone and acetaminophen. Apadaz is used for short-term management of acute pain severe enough to require an opioid analgesic and for which other treatments are inadequate, according to a press release.

“The approval of Apadaz is a significant milestone for KemPharm as it creates the opportunity to introduce what we believe is a differentiated product for the short-term management of acute pain,” Travis Mickle, PhD, KemPharm president and CEO, said in the release. “Based on its unique properties, we firmly believe there is a commercial pathway for Apadaz in what is a very high-volume market. We are excited by the opportunity Apadaz offers to patients and for physicians who now have the option of prescribing a differentiated product.”

Reference:

www.kempharm.com